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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

About PREVYMIS® (letermovir)

PREVYMIS® Infusion Prescribing Information Great Britain / Northern Ireland [External links]
PREVYMIS® Tablets Prescribing Information Great Britain / Northern Ireland [External links]

A prophylactic option for CMV reactivation in adult R+ allogeneic HSCT recipients

PREVYMIS is the first and only CMV terminase inhibitor indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).1

With its novel mechanism of action, PREVMYIS targets a component of the terminase complex involved in viral DNA cleavage and packaging.1 Cross-resistance is therefore not likely with agents with a different mechanism of action.1

 

Oral and IV administration

PREVYMIS is now available as either tablets or intravenous (IV) infusion1,2

The flexible administration options mean that cytomegalovirus (CMV) prophylaxis can be initiated early, from Day 0 post-haematopoietic stem cell transplant through to Day 100,1,2 without disruption if a patient becomes unable to take oral therapy.3

How is PREVYMIS taken?1,2

The recommended dose of PREVYMIS is 480 mg once daily. If PREVYMIS (oral or IV formuatlion) is co-administered with ciclosporin, the dosage should be decreased to 240 mg once daily.

240 mg film-coated TABLETS Box packaging for tablets 240 mg concentrate for solution for INFUSION Glass vial packaging for injection fluid
For oral use only For IV use only
Each film-coated tablet contains 240 mg of letermovir Each vial contains 240 mg (12 mL per vial) of letermovir
Tablet(s) should be swallowed whole Requires dilution prior to administration through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Can be taken with or without food Should be administered by IV infusion via peripheral or central venous catheter using a total time of approximately 60 minutes. The entire contents of the IV bag should be administered.
Should not be divided, crushed or chewed Should not be administered as an IV push or bolus

Images are for illustrative purposes only

Switching between formulations1–4

  • Tablets and concentrate for solution for infusion can be used interchangeably without dose adjustment at the discretion of the prescriber
  • PREVYMIS should be taken at the same time each day; the formulation can be switched at the next planned dose

CMV is associated with an increased risk of overall mortality in the first year post-HSCT, independent of pre-emptive therapy use5

In a Phase 3 clinical trial, PREVYMIS demonstrated:

  • Superior efficacy in CMV prophylaxis at Week 24 compared to placebo1
  • Lower all-cause mortality vs. placebo at Week 24 post-transplant6*
  • A generally well-tolerated safety profile1
  • Once-daily oral dosing – as early as Day 0 and through Day 100 post-transplant1

Start PREVYMIS as early as Day 0 post-transplant in adult CMV-seropositive (R+) allogeneic HSCT patients1

(Not an actual patient.) *Based on a pre-specified exploratory endpoint

Study overview

Additional safety information

Contraindications1,2

  • Hypersensitivity to the active substance or to any of the excipients
  • Concomitant administration with pimozide
  • Concomitant administration with ergot alkaloids
  • Concomitant administration with St. John's wort (Hypericum perforatum)
  • When letermovir is combined with ciclosporin: concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated

References

  1. PREVYMIS 240 mg film-coated tablets Summary of Product Characteristics.
  2. PREVYMIS 240 mg concentrate for solution for infusion Summary of Product Characteristics.
  3. Marty FM et al. Letermovir prophylaxis for cytomegalovirus in haematopoietic-cell transplantation. N Engl J Med. 2017;377:2433–2444. Supplementary Appendix.
  4. PREVYMIS Patient Information Leaflet.
  5. Green ML, Leisenring W, Xie H, et al. Cytomegalovirus viral load and mortality after haematopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective cohort study. Lancet Haematol. 2016;3:e119-e127.
  6. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. N Engl J Med. 2017;377:2433–2444.
  7. Data on file; AINF-1251990-0000, available upon request from MSD.

Supporting documentation

PREVYMIS® Infusion Prescribing Information Great Britain / Northern Ireland
PREVYMIS® Tablets Prescribing Information Great Britain / Northern Ireland

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GB-CYT-00321 | Date of Preparation: July 2022